US 7276071 B2
A device and method for enhancing the surgical replacement of defective natural eye lenses with an intraocular lens. The device is an intraocular lens injector that prevents an intraocular lens from uncontrollably rotating or flipping as it is advanced towards a mammalian recipient's eye, while providing an ideal lens exit orientation to help reduce the occurrence of trauma. The lens injector comprises an insertion tube having a loading port and an ejection port, a plunger, a loading carriage, and a lens carrier. In one embodiment, the insertion tube allows for the controlled insertion of a lens by rolling one side of the lens onto itself as the lens is guided through the ejection port using a guide displaced in the insertion tube from a position near the loading port to the end of the ejection port. In an alternative embodiment, controlled insertion is achieved by rolling both sides of the lens at varying degrees so that one side eventually encircles the other side.
1. A device for inserting an intraocular lens into a mammalian recipient's eye, comprising:
(a) a removable lens carrier comprising an encasement chamber having a distal end and a proximal end, and a pair of guides for holding the intraocular lens;
(b) an insertion tube comprising a loading port having first and second chambers adapted to communicate with each other, and to converge to form an ejection port having a guide ridge;
(c) a loading carriage comprising a docking platform and a removable loading carriage cover having a lens depressor; wherein the size and shape of said docking platform are adapted to complement those of said removable lens carrier, such that said removable lens carrier may be securely fastened onto said docking platform with said proximal end of said encasement chamber positioned adjacent to said loading port; wherein said lens depressor and said guides are sized and shaped to allow for said lens depressor to press the intraocular lens between said guides to align the intraocular lens with said first and second chambers; and
(d) a plunger comprising a handle, a plunger support, and a rod having a tip adapted to advance the intraocular lens towards said ejection port to allow for said guide ridge to controllably orient the intraocular lens and guide the lens into the eye.
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10. A method for inserting an intraocular lens into a mammalian recipient's eye from which the natural lens has been removed; said method comprising the steps of:
(a) loading an intraocular lens having an optic and a leading haptic and a trailing haptic into a device as recited in
(b) rolling the intraocular lens tightly onto itself by pushing the intraocular lens through the insertion tube; and
(c) placing the ejection port into a small incision in the eye and advancing the tightly rolled intraocular lens into the eye.
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This invention pertains to a surgical instrument, particularly an intraocular lens injector and method for inserting an intraocular foldable lens into a mammalian eye such as a human eye.
A “cataract” is a progressive clouding of an eye's natural lens. The “lens” is a part of the eye that helps focus light onto the retina, which in turn sends visual signals to the brain. To produce a sharp image on the retina, it is essential that the lens remains clear. Once the lens becomes cloudy, light rays are hindered from reaching the retina, which can result in blindness or diminished vision. Cataract surgery is often the most effective means for restoring vision loss from cataracts.
In most cases, cataract surgery involves removing a defective, natural eye lens and replacing it with an artificial intraocular lens (“IOL”). IOLs are clear, resiliently deformable (i.e., capable of being folded or rolled onto itself) lenses that focus light onto the retina. IOLs often include a lens body, referred to as an “optic,” having an optically clear lens, and flexible fixation members, referred to as a “haptics,” which extend from the optic to securely seat the lens in the visual axis of the eye. The optic is typically 5.5-6.0 mm in diameter. Once the cataract is removed, the IOL is folded and inserted into the eye through a small incision (approximately 2.4-3 mm long) in the cornea and into the capsular bag (the capsule is the natural membrane surrounding the cataract). A small corneal incision is necessary to minimize post-operative complications such as astigmatism, leaks, inadvertent ruptures, and slowed healing. See generally U.S. Pat. No. 5,190,552 and U.S. Pat. No. 5,643,276.
Current trends in cataract surgery are towards making smaller corneal incisions. The eye is then less likely to leak during the cataract removal process, the wound is more stable after surgery, the integrity of the cornea is stronger, and post-operative astigmatism is typically reduced. The incisions have typically been made larger than needed for cataract removal to accommodate either a folded lens or an injector with a larger diameter bore. More recently, some injectors have been created to fit through smaller incisions. To do so, many of the injectors employ a rotating plunger to advance the IOL. As the IOL advances, however, the lens often rotates axially through the bore of the injector such that the orientation upon ejection is difficult to control. A successful IOL insertion often depends on the surgeon's ability to control the orientation of the IOL as it is inserted into the eye. The orientation of the lens is critical for both the stability of the lens and the overall refraction of the eye. In some instances, the surgeon must extend the initial incision, so that the IOL orientation can be corrected. The axial rotation of the IOL also causes the haptics to rotate. As the haptics swing back-and-forth during injection, the posterior capsule can be cut. Loss of integrity of the capsule can cause multiple problems, including retinal tears or simply dropping the lens into the vitreous cavity.
U.S. Pat. No. 5,772,667 describes an intraocular lens injector for reducing the damage inflicted upon an intraocular lens during compression and insertion into an eye by rolling the lens into a tight cylindrical tube that can then be inserted into the eye.
U.S. Pat. No. 5,643,276 describes an apparatus and method for inserting a folded intraocular lens into an eye, comprising an insertion tube, an injector rod, and a rotation assembly for rotating the injector rod. The intraocular lens is oriented during insertion by rotating the injector rod as the intraocular lens is urged through the insertion tube to reduce the risk of eye damage as the intraocular lens enters the eye.
U.S. Pat. No. 5,190,552 describes an injector for injecting a temporarily folded intraocular lens in a controlled manner, by folding the lens into the injector so that the lens haptics protrude from a tube slot in the injector during insertion.
U.S. Pat. No. 5,123,905 describes an intraocular lens injector and method for controlled injection and unfolding of an intraocular lens in an eye comprising a head for partial insertion into a minimum size eye incision, and a device to push the folded lens through the head.
An unfilled need exists for a surgical instrument that enhances the ability to replace defective natural eye lenses with an IOL by eliminating or nearly eliminating the need to extend the corneal incision or to reorientate the IOL once it has been injected into the patient's eye.
We have discovered an inexpensive device and method for enhancing the surgical replacement of defective natural eye lenses with an intraocular lens. The novel invention is a standardized lens injector that allows for the implantation of various types, and prevents the lens from uncontrollably rotating or flipping as it is advanced towards the receiving eye, while providing an ideal lens exit orientation to help reduce the occurrence of eye trauma. The lens injector comprises an insertion tube having a loading port and an ejection port, a plunger, a loading carriage, and a lens carrier. In one embodiment, the insertion tube allows for the controlled insertion of a lens by rolling one side of the lens onto itself as the lens is guided through the ejection port, using a guide displaced in the insertion tube from a position near the loading port to the end of the ejection port. In an alternative embodiment, controlled insertion is achieved by rolling both sides of the lens to varying degrees so that one side eventually encircles the other side.
The general purpose of this invention is to provide a reliable, inexpensive means to replace damaged eye lenses with an IOL (e.g., Sensar and SI40 (Advance Medical Optics, Inc., Santa Ana, Calif.); MA60 and MA30 (Alcon, Fort Worth, Tex.); and CeeOn (Pfizer, Inc., Kalamazoo, Mich.)) by using a device capable of rolling the lens onto itself, or rolling both sides of the lens to varying degrees, such that one side eventually encircles the other side, and controllably guiding the lens into a patient's eye through a relatively small incision (preferably about 2.4-3.0 mm long, most preferably about 2.6 mm). The basic design of the device comprises an insertion tube having a loading port and an ejection port, a plunger, a loading carriage, and a lens carrier. In one embodiment, the insertion tube is a conically-shaped device comprising a receiving chamber and a guide chamber that converge at a location near the ejection port to form an ejection chamber having a guide ridge. In an alternative embodiment, the conically-shaped insertion tube comprises two receiving chambers that converge to form an ejection chamber having a guide ridge near the ejection port. Preferably, all components should be made of a biologically inert and sterilizable material, and should have a relatively high mechanical strength, such as polymethyl methacrylate, plastic, stainless steel, or titanium.
There are several advantages to the novel device. First, the potential for damaging the eye (e.g., iris, anterior chamber, posterior capsule, etc.) during lens implantation is substantially reduced. The need to reorientate the lens once it is positioned in the eye is nearly eliminated because the orientation of the lens as it is ejected into a recipient's eye is controlled. Second, post-operative astigmatism should be substantially reduced. The need to apply stitches is nearly eliminated because the lens can be implanted through a small incision capable of forming a water-tight, self-healing seal.
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A preferred method of implanting an IOL 24 using lens injector 2 is to first bathe IOL 24 and all lens injection surfaces that may come into contact with IOL 24 in a viscous substance capable of lubricating IOL 24 to allow the IOL to glide through the injector, such as a viscoelastic gel (e.g., Healon, Healon 5, and Healon GV; Pfizer, Inc., New York, N.Y.). A viscoelastic gel also provides a liquid barrier that minimizes damage that may arise when the edges of optic 29 and haptics 26 and 28 make contact with the eye's capsular bag. IOL 24 is then placed on top of guides 22 in a relatively flat position, with leading haptic 26 extending towards proximal end 20, and trailing haptic extending towards distal end 18. Leading haptic 26 should be on the same side as guide chamber 46 when using insertion tube 10 as depicted in
The complete disclosures of all references cited in this specification are hereby incorporated by reference. In the event of an otherwise irreconcilable conflict, however, the present specification shall control.
Citations de brevets